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Bulletin Publishing Group is a division of OTC Publications Ltd Registered Office: 4 Poplar Road, Dorridge, Solihull B93 8DB, UK. Registered in England No 2765878 OTC27-06-14p1_OTC15/11/2005 p1&24 26/06/2014 16:39 Page 1

27 June 2014

COMPANY NEWS 3 Damier makesmajor move BioGaiastrikes UK deal 3 with Nestlé Global scalenot keyfor 4 MerckOTC chief with Dutch portfolio deal NBTY givesVitaminWorld 6 a“modernnew direction” amier –the recently-established invest- Ceutahires GBT 6 Dment fund led by Yvan Vindevogel – in Latin America has made its first major acquisition by spend- Walgreens plans for 7 ing an undisclosed sum on aportfolio of fullBootstakeover consumer healthcarebrands in the Nether- lands from Japanese firm Takeda. GENERAL NEWS 8 The deal –struck through Damier’sVision Healthcare subsidiary –has giventhe fund seven NHS Scotland says e-cigs 8 Damier has snapped up arange of consumer arepreferabletocigarettes consumer healthcare brands, which generated combined annual sales of over C10 million. healthcarebrands from Takeda in the Netherlands PRAC reviews 8 ibuprofen risk Led by the Vision sun-care range –which development –said the acquisition and the accounts for around C5 million of the portfo- agreement with Vemedia would “enhance the AESGPand WSMI 9 tacklekey issues lio’stotal turnover–the deal also includes the market penetration and market share” of the After Bite insect bite treatment; the Ecosym products it had acquired. Warnerytargets triple win 10 with switch oral-care line; the Glucadol glucosamine-based Vemedia wasa“specialist in building and food supplement; the Luuf cough and cold balm extending established brands in local markets”, Rasi recognises 11 need for change for children; the Pantozol Control heartburn Vindevogel pointed out, adding that the distri- brand; and the Zinolium cold-sore treatment. bution of well-known brands from third par- Collaborationkey to 12 consumer safety In parallel to the agreement with Takeda, ties fitted perfectly into Damier’sstrategy. ANEFPspeeds up 14 Damier has struck adistribution deal with “[Damier] intends to launch some of the ac- marketing endorsement Dutch consumer healthcare player Vemedia quired products in other countries as well, and –inwhich Damier holds a25% stake–todis- therefore we will heavily invest in geographi- MARKETING NEWS 15 tribute the products. cal growth,”herevealed. Vindevogel –co-founder of the OTCfirm Aspokesperson for Damier told OTC bul- Sanofi adds IcyHot to its 15 Omega Pharma and akey figure in Vemedia’s ■ Continued on page 6 Dorflex portfolio in Brazil AustralianGuild extends 15 GoldCross line J&Jairs Sinutab creative 16 for SouthAfrican winter Abbott agrees deal for Veropharm Biocalth claims banned by ASA 16 bbott has agreed to pay around US$630 companywill also gain Veropharm’sRussian Flen Pharma stickers aim 17 Amillion (C462 million) for Russian OTC, manufacturing sites in Belgorod, Pokrovand to helpreduceburnrisk prescription and wound-care products firm Voronezh, as well as afurther plant that is cur- Bion 3packaging is 17 Veropharm. The transaction comes barely a rently being constructed. refreshed in Russia month after the US companystruck aUS$3.3 Abbott anticipates Veropharm’sportfolio FEATURES 20 billion deal for Latin Americanbranded gener- of more than 100 products adding US$150 mil- ics player CFR Pharmaceuticals (OTC bulletin, lion to its turnovernextyear.Inthe first quar- Innovation key to driving 20 30 May 2014, page 2). ter of this year,the Russian companyincreased OTC market “Through this acquisition, Abbott will ob- its turnoverby9.3% to RUB1.31 billion (C28.5 tain aportfolio of medicines that is well align- million), of which nearly three-quarters, or REGULARS ed with its current pharmaceutical therapeutic RUB948 million, came from prescription drugs. Events – Our regularlisting 19 areas of focus in women’shealth, central ner- Under the terms of the deal, Abbott will vous system, cardiovascular and gastroenterol- pay Veropharm’sholding company, Garden People – P&Gexecutive to replace 23 MackeyasCHPAchairman ogy,while also adding an offering in the field Hills, between RUB13.6 billion and RUB17.0 of oncology,” the US firm noted. billion, depending on the stakeheld by Garden People – O’Loughlin next 23 PGEU president Upon completion –which Abbott expects Hills. Abbott will also assume RUB4.7 billion during the fourth quarter of this year –the US of net debt. Gen Awards F.Pg Ad 10-6-14_Layout 111/06/2014 13:54 Page 1

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Alternatively,contact [email protected] or call +44 1564 777550 OTC27-06-14p2-7_Layout 1 26/06/2014 16:39 Page 3

COMPANY NEWS OTC

BioGaiaDistributionAgreements strikes UK deal with Nestlé

ioGaia is set to expand its presence in million deal with Nestlé which gave the Swiss Bthe UK and Ireland after signing an ex- companyaperpetual licence to use BioGaia’s clusive distribution agreement with Swiss food Lactobacillus reuteri probiotic in its infant- and drinks giant Nestlé. formula products (OTC bulletin, 29 Febru- Under the terms of the deal, Nestlé Nutrition ary 2012, page 6). UK has the exclusive rights to sell in the UK Meanwhile, BioGaia’sprobiotic drops will and Ireland BioGaia’s ProTectis baby drops soon be available in India, after it signed adis- and ProTectis baby drops with vitamin D. Both tribution deal with Swiss firm Pharma Base. products contain the company’s Lactobacillus The deal will see Pharma Base cooperate reuteri probiotic formula. with alocal Indian distributor to market and sell BioGaia said the launch in both markets BioGaia’s ProTectis baby drops in the Indian was planned for the beginning of 2015. state of Maharashtra and the Mumbai region. Nestlé has been granted the exclusive rights to sell BioGaia’s ProTectis baby drops in the UK and Ireland Commenting on the agreement, Peter Roths- The drops will be sold under BioGaia’sown child, BioGaia’s president, said he was “con- brand, with the launch planned for 2015. In May 2013, BioGaia announced it would be vinced” that the company’ssales in the UK and Headquartered in Freienbach, Switzerland, devoting time and resources to finding distrib- Ireland would “expand quickly” givenNestlé’s Pharma Base has research and development fac- utors in the so-called BRIC countries –Brazil, existing presence in both markets. ilities and manufacturing plants located in India. Russia, India and China (OTC bulletin,10 The deal is the latest tie-up between the Commenting on the deal, Rothschild said May 2013, page 10). twofirms and follows an agreement signed in Pharma Base had “extensive experience” in the Later that month, the company revealed it March that will see BioGaia carry out clinical Indian market. had signed a distribution deal with Chinese studies and develop new products for Nestlé BioGaia had been trying for a“long time” firm Beijing Keyuan Xinhai Pharmaceutical (OTC bulletin, 28 March 2014, page 8). to find a“suitable waytoenter the large Indian (OTC bulletin, 31 May 2013, page 3). In February 2012, BioGaia agreed a C50.8 market”, he noted. In November, BioGaia secured a distribution agreement for Brazil with local pharmaceutical companyAché (OTC bulletin,29November IN BRIEF 2013, page 3). Speaking in February,Rothschild noted that ■ VA LEANT has taken its bid for ophthalmics 16 June 2014, page 4). Following the rejection, BioGaia had signed up one Russian distributor. and cosmetics specialist Allergan hostile after Valeant said it would go directly to Allergan’s However, the companywould require “several the firm’s board rejected a revised takeover shareholders with its offer of US$72.00 (C52.77) partners” due to the size of the country (OTC offer.Allergan’sboard said the offer “substan- per share plus 0.83 Valeant shares. bulletin, 21 February 2014, page 9). tially undervalued” the company(OTC bulletin, OTC OTC

27 June 2014 Number 425 published 20 times a year – twice monthly, except Subscription enquiries: monthly in July,August, December and January, and As left, or [email protected] Editor: Matt Stewart delivered by air mail – and a free weekly email Editor-in-Chief: Aidan Fry newsflash news@OTCbulletin published at least 45 Te rms & Conditions: No partof this publication may be times a year. Individual annual subscriptions in Europe copied, reproduced, stored in aretrieval system, distributed Production Editor: Jenna Meredith or transmitted by anymeans, including electronic,mechanical, cost £715 (additional copies at the same address Assistant Editors: Liudmila Kotko, Marie McEvoy photocopying or recording, without the prior written £415); outside Europe £745 (£445). Business Reporter: Tom Gallen permission of the publisher,orunder the terms and conditions The 20 OTC bulletin newsletters arenow available as a of aGlobal Site Licence or of alicence issued by the Copyright Contributing Editor: David Wallace Licensing Agency (CLA) in London, UK, or rights bodies in digital edition, OTC bulletin-i, for either Apple or Advertising Controller: Debi Minal other countries that have reciprocal agreements with the CLA. Android mobile devices at a cost of £975.This Director of Sales & Marketing: Val Davis subscription includes news@OTCbulletin. Neither may this publication be exported, distributed or Awards Manager: Natalie Cornwell circulated by any means outside the staff who work at the Managing Director: Mike Rice A combined annual subscription to OTC bulletin address to which it is sent by the publisher without the (hard-copy newsletter plus weekly email newsflash) and prior written permission of the publisher. Editorial enquiries: OTC bulletin, OTC bulletin-i (digital edition) costs £1,175. 4 Poplar Road, Dorridge, Solihull, While due care has been taken to ensure the accuracy of West Midlands B93 8DB, UK. Single hard-copynewsletters cost £50 each. Subscription information contained in this publication, the publisher makes no claim that it is free of error and disclaims any liability Website: www.OTC-bulletin.com rates may be adjusted to cover any period and can be whatsoever for any decisions or actions taken as a result of backdated. Subscriptions mayonlybecancelled at expiry. Te l: +44 (0)1564 777550 its contents. Fax: +44 (0)1564 777524 Corporate subscriptions: Global Site Licences are Email: [email protected] © OTCPublications Ltd.All rights reserved. OTC bulletin® available to companies.These provide in-house electronic is registered as a trademark in the European Community. Advertising enquiries: access for staff to OTC bulletin or OTC bulletin-i As above, or [email protected] and [email protected] ask foraquotation. ISSN 1742-0784. Such licences are supplied strictly on the condition that Company registered in England No 2765878. SUBSCRIPTIONS both publications are the intellectual property of the Individual subscriptions: An OTC bulletin annual copyright holder,OTC Publications Ltd, and are Printed by Warwick Printing Company Limited, subscription includes this hard-copy newsletter protected by copyright, trademark and other laws. Leamington Spa CV31 1QD, UK.

27 June 2014 OTC bulletin 3 OTC27-06-14p2-7_Layout 1 27/06/2014 08:53 Page 4

OTC COMPANY NEWS

BusinessStrategy Global scalenot key for Merck OTC chief

tisacompany’sbrands, not acompany’s Merck’sglobal allergy business Allergophar- “It couldn’tbeabetter time to join and lead Isize, that is keytosuccess in the OTCmar- ma –joined Consumer Health alittle over 18 the business into the next phase of growth and ket, according to the newpresident and chief months after the firm’sthen chief financial success,”Kemmerich-Keil insisted. executive officer of Merck KGaA’s Consumer officer Matthias Zachert described the business “When it comes to the consumer health- Health division Uta Kemmerich-Keil. as “somewhat the stepchild of Merck” (OTC care market, Ithink we are in aluckysituation Speaking exclusively to OTC bulletin,Kem- bulletin,18August 2011, page 7). as there is alot of future growth to come that we merich-Keil said that the division would focus Although Consumer Health had a“very want to grasp,”she noted. “When you look at the on leveraging the “very strong equity” of its healthygross margin” of “around 69-70%”, business itself, there are lots of opportunities on strategic brands, rather than chasing transform- the division’soperating margin had only been the organic side as well as on the inorganic side.” ational deals just to gain global market share. in the single digits, Zachert remarked. “Wehavestrategic brands with very strong Having taken overfrom Udit Batra in May Following on from Zachert’scomments, equity and the first mandate will be to build (OTC bulletin,28March 2014, page 1), Kem- Merck raided Novartis and recruited Batra in on what we have in our hands as there is so merich-Keil said she had found the division “in September 2011 to lead aturnaround. Batra much more value that we can generate out of an excellent condition across all its strategic took Consumer Health “back to basics”, with that,”Kemmerich-Keil stated. brands and across all the keymarkets”. the business concentrating on its keybrands “Asanexample, not all of our keybrands are “With our 3x3 strategy of developing a and biggest markets, and by the end of 2013 the in all of our keymarkets,”she explained. “When minimum of three leading brands in keycate- companywas starting to see the results (OTC you look at the probiotic multivitamin Bion, gories and achieving at least a3%market share bulletin,28March 2014, page 20). it is very successfulincountries likeFrance or across the company’stop 15-20 markets,”Kem- In March, the chairman of Merck’sexecu- Chile butwehaven’tevenintroduced it into merich-Keil pointed out, “we have aclear tive board, Karl-Ludwig Kley, announced that the Brazilian market.” and simple plan for sustainable growth.” Consumer Health had successfullyturned itself “So, Ithink there is alot more to be done on “This idea of having leading brands with a around in 2013, increasing sales and profits the organic side to bring our keybrands into minimum market share, and making sure that and positioning itself for future growth (OTC our keymarkets,”Kemmerich-Keil said. you drive your brands in markets that have bulletin,17March 2014, page 2). “Secondly,there are very attractive markets high growth potential, is what is creating value,” Recognising the progress that had been in which we are not yet present, including China she insisted. made, Merck bolstered Consumer Health’sport- and the US,”she added, “and third, at the mo- foliowith twobrands –Neurobion and Flora- ment, there is alot of consolidation going on, Business size not of value til –from its Merck Serono prescriptiondivi- not only big butalso small in size.” “I have to admit that, to me, global business sion, adding approximately C250 million in Having joined Merck in 1999 as mergers and sizeisreally not of value in itself, especially not sales to the business (OTC bulletin,17March acquisitions controller and subsequently heading in the OTCspace,”Kemmerich-Keil said. 2014, page 1). the mergers and acquisitions team –where she When you looked at Merck’sstrategy,ithad Consumer Health’s2013 earnings before played akey role in the deal which sawMerck been brand management,she noted, not the interest and tax (EBIT) –before one-time secure the Serono business (OTC bulletin, 29 sheer size of the company, that had led to Con- items –surged to C62 million. Earnings were September 2006, page 2) –Kemmerich-Keil sumer Health’srecent successes. up from just C14.0 million in 2010 before Batra said she thought it wasabout being smart when Kemmerich-Keil also praised the ability of arrivedin2011, thanks to “improvedresource it came to in-licensing and mergers and acqui- the team she inherited from Batra, commenting allocation and tightly-managed expenses”. Sales sitions activity on that smaller,bolt-on level. on the “energy and dynamism” in the organisa- movedforward by just 0.9% to C480 million, tion, especially after the successful turnaround as negative currencyeffects offset strong org- No transformational deals of the business in the past fewyears. anic growth of 5.6% (see Figure 1). “Clearly we are looking for smaller rather “I’m abig believerinthe team approach Batra’ssuccess led to Merck promoting him than transformational deals,”Kemmerich-Keil andI’m really happywith what Ihavefound,” to head of the firm’ssubstantial Merck Millipore explained, “and we look very closely at how Kemmerich-Keil said. life sciences division, with Kemmerich-Keil these opportunities will fitwith our existing Kemmerich-Keil –previously head of stepping up as his replacement. business so we do not lose focus.” However, she reiterated, leveraging the assets Business Annual sales Change EBIT Change Consumer Health already had at its disposal (C millions) (%) (C millions) (%) wasthe core focus. Merck Serono 6,326 -1.2 893 +63.1 “I think firstly,you have to have internal cred- ibility by leveraging the assets you have in Merck Millipore 2,645 +1.1 262 +4.1 hand,”Kemmerich-Keil noted, “and that holds Performance Materials 1,644 -1.9 653 +7.2 true for the established portfolio and the two Consumer Health 480 +0.9 62 – brands we have just taken over.” Corporate and others ––-260 – “Organic growth always comes first. With that yougain credibility and you build an org- Total Merck 11,095 -0.7 1,611 +67.2 anisation that is mature enough and strong Figure1:Merck KGaA’s sales and EBIT in 2013 (Source –Merck KGaA) enough to do inorganic moves,”she added.

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COMPANY NEWS OTC

“Mergers, acquisitions and in-licensing,” growth potential within the emerging markets”, Kemmerich-Keil said, “is, for us, a means to Kemmerich-Keil said, and both had “great execute against our strategy.” bases” from which to operate and build upon. Commenting on the recent round of con- The brands had both been fully integrated solidation in the OTC industry – which has into Consumer Health, she added, and were created two new global market leaders through developing “fantastically”. the GlaxoSmithKline/Novartis joint venture and It was already becoming clear, Kemmerich- Bayer snapping up Merck & Co’s Consumer Keil said, that both brands were benefitting Care division (OTC bulletin, 25 April 2014, from Consumer Health’s commercial experi- page 1; and OTC bulletin, 9 May 2014, page ence of taking a brand to the consumer. 1) – Kemmerich-Keil said she “truly believed” “When you look at Floratil – which is pri- that if Merck Consumer Health executed against marily an OTC brand – in the Brazilian market its strategy the business would “gain lots of we started a television campaign in one region Uta Kememrich-Keil, president and chief executive value” and compete. of the country that was such a hit we rolled it officer of Merck KGaA’s Consumer Health division, said that strong brand management, not massive out to the rest of the country,” she noted. scale, would lead the business to success Concentrate on the assets that you have With Neurobion – which had a more even “Even though compared to these big players sales split between OTC and prescription vari- in, I don’t see that many bigger candidates in- we are rather small, it is key to concentrate on ants – the firm had continued with medical de- ternally,” she pointed out. “When you look at what we have first and smartly look at how tailing with doctors, Kemmerich-Keil said, but the vitamins, minerals and supplements (VMS) we can expand geographically and add some had been working more intensively with phar- or cough and cold areas there are not that bolt-ons,” she argued. “Honestly, I’m not 100% macists and promoting directly to consumers. many candidates that I can think of.” sure that a big, big size helps you a lot.” Asked about plans to roll-out the brands “Sure, it is important to allow consumers “There are not that many global brands, so into new markets, Kemmerich-Keil insisted that to take more care of themselves and it is with what is important is that you have brands that the “first step” would be to “bring these brands good reason that many of our competitors talk the consumer really appreciates and brands that to excellence” in the markets where they were about switching. “It’s a good trend,” Kem- are well-recognised by the consumer, and that already present. merich-Keil noted, “but for our categories at for me is more a country-by-country view,” In parallel, Consumer Health would look the moment at Merck I don’t see many.” Kemmerich-Keil insisted. at which new markets would be a good fit “I don’t have this global market share think- for the brands, she added. “These brands have Landmark consumer healthcare brands ing on the OTC side,” she added. “I do see the great potential so we will clearly look into the Turning to how Consumer Health would value of that in other areas and in other busi- geographies in which this makes sense. But look in five years time, Kemmerich-Keil said nesses where this type of scale matters, but for this year the first priority is to show what is she hoped to see the firm’s existing strategic the branded OTC industry I don’t really see the possible in the markets where they have al- brands become “true landmarks” in the eyes of big advantage there.” ready been introduced.” consumers. “For example, when they think of Turning to how Consumer Health will foster While the transfer of Floratil and Neuro- a probiotic multivitamin they think of Bion.” the organic growth it wants to achieve over the bion to Consumer Health had made sense as “I believe we have such strong brands with next few years, Kemmerich-Keil said that the both brands had products with OTC status, such potential that I want to make sure that two brands the division had recently gained Kemmerich-Keil said she did not see much consumers see that and start loving our brands. – the Floratil probiotic range and the Neuro- opportunity for traditional prescription-to-OTC That would be my biggest wish for the long- bion vitamin B brand – would play a key role. switches at Merck. term,” she added. Both Floratil and Neurobion had “so much “If you look at the categories we are active OTC

IN BRIEF ■ BAYER said that it had issued twohybrid bonds with atotal volume of C3.25 billion as afirst step in refinancing the US$14.2 billion (C10.4 billion) bridging loan taken to purchase Merck &Co’sConsumer Care unit (OTC bul- letin,9May 2014, page 1). The German phar- maceutical giant said that demand for the bonds had been “exceptionally strong” and the order book had been “more than three-times over- subscribed”. Werner Baumann, Bayer’schief financial officer,said the transaction marked an “important step” in the financing of the deal for Merck Consumer Care and the strong inter- est in the bonds put Bayer on agood footing to Merck Consumer Health has expanded its portfolio of strategic brands by adding the Floratil probiotic and Neurobion takefurther financing measures. Bayer expects vitamin Blines from Merck Serono. Floratil and Neurobion join the Bion multivitamin line, Cebion vitamin Crange, Femibion women’s health supplement, Kytta natural pain reliever, Nasivin nasal sprays, Sangobion anaemia to complete the deal before the end of 2014. supplement, Sedalmerck analgesics and Seven Seas cod liver oil products OTC

27 June 2014 OTC bulletin 5 OTC27-06-14p2-7_Layout 1 26/06/2014 16:39 Page 6

OTC COMPANY NEWS

BusinessStrategy BusinessStrategy NBTY gives Vitamin World Ceuta hires GBT a “modern new direction” in Latin America lobal outsourcing specialist Ceuta Health- BTY said it was “rebranding and rep- Gcare International Alliance has signed up Nositioning” its vitamins, minerals and sup- consumer healthcare firm GBT Pharma to plements (VMS) retail chain Vitamin World to identify for its members newopportunities in give the US business a“modern newdirection”. Latin America. The retailer and wholesaler has unveiled a Describing GBT as a“specialist in driving newVitamin World logo and anew tagline for international market entry for consumer health- the retail chain: “Nutrition from the source.” care companies”, Ceuta said the firm had been In addition to the logo and tagline, NBTY appointed to “identify and secure key health said it had developed newpromotional mat- and beauty distributor partnerships”, within erials for its own-label brands and would intro- South, Central and Latin American markets. NBTY said rebranding its Vitamin World stores would duce a new store design to all of its Vitamin give the business a “modern new direction” Key markets would include Brazil, Chile, World outlets across the US. Colombia, Costa Rica, Ecuador,Panama and The companysaid it had also opened anew formed consumers of the advantages of adding Peru, the company noted. Vitamin World flagship store in Garden City, aparticular supplement to their diet, he added. Peter Burrows, Ceuta’sinternational busi- New York, US. Noting that the rebranding of stores was ness development director,claimed that GBT Jack Krause, Vitamin World’spresident, told underway, Krause revealed that the company had a “proven track record in managing and OTC bulletin that the strategy behind the re- had already seen “great results” in terms of developing international market opportunities”. brand wasto“more effectively communicate to increased sales and more frequent visits by “Weare delighted to be working with GBT consumers Vitamin World’spoints of difference” consumers. as our chosen partner to identify the right cal- from other VMS outlets. Vitamin World sells both its ownbrand and ibre of partners to represent our unique inter- These differences included the nutrition branded VMS, sports nutrition and health and national alliance,”Burrows said, “and to help advice consumers could receive in-store from beauty products through more than 420 stores drive international growth in these regions.” Vitamin World employees, Krause noted, and across the US and online at vitaminworld.com. The founder of GBT,Gian Trepp, said the the fact that the company manufactured the NBTY reported turnoverdownby0.1% to companywould use its “experience and strong majority of its products. US$234 million (C172 million) at its North networks” within Latin America to find the Expanding on the alterations to Vitamin American Retail division –which includes sales right distribution partners to represent members World outlets, Krause explained that the firm from Vitamin World – in the year ended 30 of the Ceuta Healthcare International Alliance. had wanted to develop a“less cluttered and less September 2013. OTC confusing store” compared to its competitors. The company’stotal sales had advanced by To help consumers find products suited to 5.4% to US$3.16 billion, NBTY said, as turn- Trading Update their needs, Vitamin World had introduced “pro- overimproved atits Wholesale, European Re- duct benefit signs”, Krause said. These signs in- tail and Direct Response/E-commerce divisions. Bosnalijek reports OTC stable year so far Mergers&Acquisitions osnian prescription and OTCpharmaceu- Damier makes move with Dutch deal Bticals firm Bosnalijek said that its business had stabilised in the opening half of 2014. ■ Continued from front page build a “portfolio of small-to-mid-size com- Nedim Uzunovic´, the company’s acting -letin that giventhe “intimate nature” of the two panies and brands throughout Europe” (OTC chief executive officer, said the management companies’ relationship, Vemedia was“by far” bulletin, 7 February 2014, page 13). team had “got to grips” with the corrected its preferred partner in the Netherlands and “Damier will operate in twoways,”Vinde- financial statements from previous years and potentially for other markets as well. vogel explained, “and invest up to C50 million could nowpresent a“reliable and realistic finan- Damier would expand on its international in several kinds of businesses.” cial report to all shareholders and stakeholders”. ambitions in the near future, the spokesperson “On the one hand, we will build up ahealth- An international auditing companyhad been said, and at this stage no market had been ruled caregroup. By that, Imean we will try to buy hired to inspect and control all of the company’s out, but Belgium and neighbouring countries brands, companies, distribution platforms and financial reporting, Uzunovic´ said, as part of would be a priority. bring them together,” he maintained. the “clean start” reviewofthe firm’sfinancials Talking exclusively to OTC bulletin earlier “On the other hand, we will operate our own for the 2011-2013 period. this year, Vindevogel said Damier planned to small private-equity fund, where co-investors The firm reported a profit of BAM2 mil- seek out “well-established brands or innovative can come along and co-invest with Damier in lion (C1.0million) in the period, compared to a technologies in the consumer healthcare, beauty, minority or majority stakes in companies.” BAM1.4 million loss in the prior-year period. personal care and medical devices sector” and OTC OTC

6 OTC bulletin 27 June 2014 OTC27-06-14p2-7_Layout 1 26/06/2014 16:39 Page 7

COMPANY NEWS OTC

Third-QuarterResults Walgreens plans for full Boots takeover

algreens has begun preparations for uating the proposed transaction, he added. Alliance Boots wasontrack to exceed the com- Wtaking full control of Alliance Boots, The timing and structure of the proposed pany’ssecond-year estimate, he said. according to the US drugstore chain’spresident takeoverwas currently being assessed, Wasson Combined synergies with Alliance Boots and chief executive officer Greg Wasson. noted, as well as cost-reduction initiativesand were now expected to reach US$400 million Speaking as Walgreens posted a5.9% rise in the creation of combined management teams. to US$450 million in the year ended 31 Aug- sales in its third-quarter ended 31 May 2014, Wasson said that Walgreens wasplanning to ust 2014, Wasson pointed out, ahead of the Wasson said the firm wasworking on plans to makeanannouncement on the outcome of these previously-stated target of US$375 million initiate the second part of its two-part trans- discussions between late July and August 2014. to US$425 million. action to acquire Alliance Boots. Walgreens would also produce by August Meanwhile, Walgreens’ turnoverinits third Walgreens completed its initial investment 2014 new financial targets for the combined quarter grew by 5.9% to US$19.4 billion. in Alliance Boots at the start of August 2012, business for fiscal year 2016, he added. Prescription sales, which accounted for paying US$6.7 billion (C4.9 billion) in cash and 64.4% of the total, had increased by 8.4%, Wal- shares for a45% stakeinthe privately-owned Working through complex issues greens noted, while front-end comparable sales firm (OTC bulletin,10August 2012, page 8). “Weare working through complexissues in in stores open ayear or more –including OTC It has six months from February 2015 to acquire planning for step two of the transaction,” products – had advanced by 2.2%. the remaining 55% stake for US$9.5 billion. Wasson said, “and we are taking the appropriate Customer traffichad slipped back by 0.7%, Wasson revealed that he wasworking in col- time to come to the right resolution for the com- the company pointed out, but basket size had laboration with Alliance Boots’ executive chair- bined enterprise.” grown by 2.9%. man Stefano Pessina to present to Walgreens’ Turning to the financial progress of the strate- As of 31 May 2014, Walgreens wasoperat- board of directors the strategy for combining the gic partnership, Wasson noted that it “continued ing around 8,683 locations across all 50 US twofirms. Walgreens’ senior management team to generate significant benefits”. states, the District of Columbia, Puerto Rico, had already made “significant progress” eval- Walgreens’ joint synergy programme with Guam and the US Virgin Islands. OTC

27 June 2014 OTC bulletin 7 OTC27-06-14p8-14_Layout 1 26/06/2014 16:18 Page 2

OTC GENERAL NEWS

Regulatory Af fairs Regulatory Af fairs NHS Scotland says e-cigs PRAC reviews arepreferable to cigarettes ibuprofen risk he European Medicines Agency’s(EMA’s) sers of unlicensed nicotine-containing prod- were aimed at deprivedcommunities where trad- TPharmacovigilance Risk Assessment Com- Uucts–including e-cigarettes –“should not itional smoking-cessation services or approaches mittee (PRAC) is to consider whether high- be advised to discontinue use of such products had failed to engage smokers, she added. dose ibuprofen should be subject to warnings if it risks arelapse to smoking”, according to The guidance presents “tobacco harm-re- similar to those recently placed on medicines National Health Service (NHS) Health Scot- duction approaches” for highly nicotine-depen- containing diclofenac. land’sguidelines on smoking cessation. dent smokers or those smokers who are unwill- At its June meeting, the PRACdecided to An addendum to NHS Health Scotland’s‘A ing or unable to quit in one step. Smokers who begin areviewtoevaluate the cardiovascular guide to smoking cessation in Scotland 2010’ choose to use e-cigarettestocut down on smok- risks linked with regularly taking 2,400mg ibu- points out that while it is “strongly preferable” ing should have access to smoking-cessation profen per day for long periods, the committee forsmokers trying to quit to use licensed nico- services including behavioural support, it notes. said, noting that the reviewexcluded topical tine-containing products, using e-cigarettes is The decision by NHS Health Scotland to medicines. Observing that ibuprofen wasusu- preferable to continued cigarette smoking. include advice on e-cigarettes in its stop-smok- ally taken at lower doses and for short periods The priority for organisations responsible ing guidelines comes as the debate continues of time, the PRACinsisted that there was“no forpublic health, tobacco control and smoking- to rage overe-cigarettes and howthe products suggestion of asimilar cardiovascular risk with cessation services in the country,the guidance should be regulated. ibuprofen as used by the overwhelming maj- says, should be to prevent ex-smokers from re- ority of patients”. turning to cigarettes. Therefore, continues the Do not suppress e-cigarettes “Ibuprofen is one of the most widely-used guidance, users of e-cigarettes should not be Earlier this month, agroup of influential medicines for pain and inflammation,”the prevented from “benefitting from evidence- researchers and public health specialists called PRACpointed out, “and has awell-known based smoking-cessation support”. on the World Health Organization (WHO) not safety profile, particularly at usual doses.” Smokers who are attempting to quit should to “control and suppress” e-cigarettes as it could However, the PRACsaid that data –in be offered licensed nicotine-replacement prod- hamper harm-reduction efforts (OTC bulletin, particular the results of an analysis of clinical ucts, notes the guidance. E-cigarette users should 16 June 2014, page 9). trial data –had suggested that the cardiovascu- be informed that there is “very little evidence In an open letter to the WHO, the group larrisk with the non-steroidal anti-inflammato- on the quality,safety or effectiveness” of the said that it was“deeply concerned” that classi- ries (NSAIDs) diclofenac and high-dose ibupro- products. However, continues the guidance, fying e-cigarettes and similar products as tobac- fen might be “similar to the known risk” with users should also be advised that based on “limit- co –and their inclusion in the Framework Con- another form of NSAID, COX-2 inhibitors. ed evidence”, e-cigarettes are “expected to be vention on Tobacco Control (FCTC) –would In 2013, the PRACconsidered the data in considerably less hazardous than smoking”. do “more harm than good, and obstruct efforts relation to diclofenac and recommendedthat Explaining the rationalebehind the updated to meet targets to reduce non-communicable patients with serious underlying heart condi- guidance, Fiona Moore, public health adviser at diseases” caused by smoking. tions should not use diclofenac due to asmall NHS Health Scotland, said that the addendum The WHO said it had yet to decide what increased risk of heart attack and stroke(OTC offered “important newoptions” for smokersin recommendations it would makeonthe use bulletin,26July 2013, page 13). The commit- Scotland looking to quit. These newoptions of e-cigarettes. tee wasnow considering the same data in re- OTC lation to high-dose ibuprofen, it revealed. Furthermore, the committee said it would evaluate evidence on the interaction of ibupro- ProductSafety fen with low-dose aspirin –taken to reduce the FDA issues topical acne product warning risk of heart attacks and strokes –todecide whether current advice to healthcare profes- he US Food and Drug Administration (FDA) and Neutrogena from Johnson &Johnson and sionals wassufficient. Tis warning consumers that certain OTC the Oxy skin-care range from Mentholatum, as OTC topical acne products in various formats may well as the Ambi skin-care brand, GuthyRenk- cause “rare butserious and potentially life-threat- er’sProactivline and Stiefel’sMaxClarity prod- IN BRIEF ening allergic reactions or severe irritation”. ucts and numerous store-brands. In asafety bulletin, the agencysays that Based on the information received, it is un- ■ CANADADRUGS.COM has had its whole- the “serious hypersensitivity reactions” may oc- clear whether the reactions were triggered by saling establishment licence suspended by cur “within minutes to aday or longer after the products’ active ingredients –benzoyl per- Canada’sregulatory authority Health Canada product use” and differ from the reactions al- oxide or salicylic acid –the inactive ingredients, over“significant concerns” with the firm’scom- ready warned about on the products’ labelling. or acombination of both, the agencypoints out. pliance with Good Manufacturing Practices The FDApoints out that the OTCacne prod- The FDAwill continue to monitor the issue, (GMP). The company’spharmacylicence re- ucts of concern are marketed under various it adds, in collaboration with manufacturers. mains valid and its website active. brand names, including Aveeno, Clean &Clear OTC OTC

8 OTC bulletin 27 June 2014 OTC27-06-14p8-14_Layout 1 27/06/2014 08:52 Page 3

AESGP MEETING OTC

AESGPIndustr yAssociations and WSMI tacklekey issues

dvertising, ingredient defence, switching Medicines Agency(EMA) to deliverinthis plained that this wasakey area where in the Aand umbrella branding are just four of the area,”headded. past, responses had been “reactive”. areas where the European and global OTCin- However, the environment for change looked But the WSMI planned to see offproblems dustry associations can work together to demon- promising, Cranz revealed, with the EMA keen before theyarose by creating a“global platform strate the value of self-care, delegates at the to “revitalise” its relationship with the AESGP for knowledge and process sharing” around in- combined 50th Annual Meeting of the Associ- to “sort out the difficulties with regards to gredient issues, he revealed. ation of the European Self-Medication Indus- switching procedures in general” and also Cranz said that the work already done by the try,the AESGP,and 18th General Assembly specifically in regards to switches which had WSMI in the context of benefit-risk assessments of the World Self-MedicationIndustry,the previously been attempted using the centralised had been extremely important in the EU. WSMI, have been told. procedure at the EMA. These newprojects would further help the Hubertus Cranz, director general of the AESGP address the “often unnecessary reg- AESGP,pointed out that the association work- Need for change ulatory hurdles” that made it “hard to bring a ed “in avery coordinated fashion” and what “One thing is clear: if the centralised proce- newmedicine either onto the market or to keep it did in Europe was“very much connected” dure cannot deliver, then there is aneed for it there, which in the context of ingredient de- to global activities. change,”Cranz insisted. fence is particularly important.” “Our objectivesare evidently related to the Furthermore, the AESGP would continue to “Overall, we feel there is still alack of under- recognitionofthe value of self-care and of dem- campaign with the WSMI for newOTC indica- standing for the right kind of rules for well- onstrating and communicating the public health tions and therapeutic areas, Cranz noted, as well established substances in comparison to new and economic value of self-care,”Cranz said. as to gain more data protection and market substances,”Cranz noted, “and this tendency to “Wealready spend significant resources on protection for switched products in the EU. measure all substances in the pharmaceutical this, butevidently this goes hand-in-hand with “This debate is very important and will be field in the same manner evidently cannot lead our day-to-day activities in all relevant political, high on our agenda in the future,”Cranz insisted. to good results for the non-prescription sector.” legislative and regulatory debates and this is on Turning to ingredientdefence, Dziekan ex- OTC aglobal as well as aEuropean level,”headded. Echoing Cranz’ comments, Gerald Dziekan, director general of the WSMI, said there wasa “huge degree of alignment between the Euro- pean and global associations”. “Our network has alot in common and in particular we want to makeself-care the foun- dation of healthcare,”Dziekan noted. Looking at collaboration on the current key challenges faced by the industry,Dziekan point- ed out that the WSMI had established work streams to tackle various pressing issues, includ- ing advertising and umbrella branding, as well as most recently switching and ingredient defence. Commenting on the switch working group –which had been establishedinMarch –Dzie- kan pointed out that a“comprehensive scope-of- work exercise had already been completed”. This work would not only address prescrip- tion-to-non-prescription switches, Dziekan said, butalso other types, such as switches that moved aproduct from behind to in front of the counter. “Wehope to develop atoolkit with acom- prehensive list of related considerations, acoun- tryinventory and an analysis of regulatory frame- works around the world,”Dziekan said, “as well as ageneral cost analysis for all types of switches and descriptions of market incentives.” Cranz said the AESGP would liketouse this work to make“real progress” with regards to switch procedures in the European Union (EU). “Certainly there will be newchallenges for the centralised procedure and for the European

27 June 2014 OTC bulletin 9 OTC27-06-14p8-14_Layout 1 26/06/2014 16:18 Page 4

OTC AESGP MEETING

WaSwitches rnerytargets triple win with switch

rescription-to-OTC switches are a“triple related savings such as less absenteeism at work.” Pwin” that can increase access to medicines, “Wehavetomove beyond the viewofOTC ease the disease burden and help save national products as just convenience products and see healthcaresystems money, according to Vin- them as integral to the healthcare system,” cent Warnery,senior vice-president of Sanofi’s Warnery stated. Global Consumer Healthcare division. There wasalso astrong commercial argu- Speaking at the recent 50th Annual Meeting mentfor switching, Warnery said, with Sanofi of the Association of the European Self-Medi- recently having benefitted considerably from cation Industry,the AESGP,inLondon, UK, following arobust switch programme. Warnery told delegates that people wanted to “Wehavebeen active in the OTCfield for takebetter care of themselves and this wasa years with aseries of local and regional brands trend industry wanted to accelerate. managed at alocal level,”Warnery pointed out, Switching wasakey tool in doing that, he “and in late 2013 the group set up aglobal insisted, and while theymust be “data driven, OTCleadership team” (OTC bulletin,25Oct- scientifically robust and highly regulated”, in the ober 2013, page 23). Vincent Warnery, senior vice-president of Sanofi’s end industry regulators needed to allowcon- “This global OTCdivision is driving world- Consumer Healthcare division, said OTC switches are sumers to have “quick and safe access to effec- wide categories with aclear focus on prescrip- atriple win for consumers, regulators and industry tive healthcaresolutions”. tion-to-OTC switches in the US, Europe and “For our industry,switching prescription other regions,”headded. outfor in-licensing opportunitiestobolster its medicines to OTCstatus is about growing our Looking at the categories that Sanofihad switch portfolio, continued Warnery,highlight- business and about facilitating this triple win,” focused on when it came to switching, Warnery ingthe firm’srecent deal with Eli Lilly for the Warnery told delegates at the meeting, which said that allergy had provenafertile area. exclusive rights to seek OTCapprovalfor the wasalso the 18th General Assembly of the “Allegra (fexofenadine) has been switched erectile dysfunction drug Cialis in Canada, US, World Self-Medication Industry (WSMI). to OTCstatus in the US, Japan and other coun- Europe and Australia (see page 11). “For the consumers,”Warnery explained, tries around the world,”hepointed out, “with Cialis represented a“fantastic opportunity”, “obviously we are talking about enhancing the great interest from consumers who have re- Warnery commented,asthere wasareal need for availability of medicines, which can offer in- ceivedaccess to this latest generation of anti- more direct yet responsible access to areliable dividuals easy and timely access to safe and histamine products.” and legitimate solution for erectile dysfunction. effective drugs.” “WehaveOTC status in the US, Japan, So, while there wasaclear consumer and Poland, Hungary and Portugal to name afew, public-health benefit to switching and astrong Timely relief from symptoms as well as Eurasia, Africa and Latin America, commercial argument, Warnery said, there re- Switch products should provide “quick re- and we have aco-existing prescription and OTC mained aneed to “evolve” the regulatory envi- lief from symptoms when time is crucial, such status where it is acceptable,”headded. ronment to makeswitch more attractive to com- as with allergic reactions or pain attacks”, he In the US, Allegra had been launched by panies, especiallyinEurope. claimed, adding that these “core requirements” the firm’sChattem subsidiary in 2011, Warnery “Weare facing today avery interesting para- could makeconsumers “co-managers of risk noted, and nowheld a“14% market share in dox here in Europe,”Warnery explained. “We and co-producers of health”. avery competitive US allergy market”. have manycountries with strong pharmacynet- In terms of the public health benefits, Meanwhile, in Japan Sanofihad created a works providing agood levelofhealthcare ad- switches provided asolution to policymak- partnershipwith local firm Hisamitsu to launch vice that does not exist in the US, and yet, so far, ers looking to reduce the disease burden, Allegra OTC, while also maintaining the drug’s we have amuch weaker switch approach.” Warnery said. prescription status, Warnery explained. “The number of OTCmedicines available in However, to do this further would require “Asaresult, as of today we have 1.5 million Europe remains lowcompared to other regions the “development of educational materials for users of the newAllegra OTC, with overhalf around the world,”Warnery claimed, “for two both pharmacists and consumers”,Warnery having not treatedbefore or previously using major reasons.” insisted. The pharmacist’srole was“gaining only first generation products,”herevealed. “One is the great variety in OTCswitch momentum”, he added, “with more and more More recently,Chattem had launched Nasa- systems from one European member state to healthcare systems relying on pharmacists to cort Allergy 24HR (triamcinolone acetonide) another,” Warnery noted, “with very fewOTC extend patient education and to monitor and following asuccessful switch application in switches having made it successfully through prevent safety incidents”. 2013 (OTC bulletin,25October 2013, page the centralised procedure.” “OTC medicines can obviously bring sub- 1), Warnery pointed out. “This is leading to agreat disparity across stantial economic savings to healthcare systems “This is the first switch at full prescription Europe of the availability of OTCdrugs,”Warn- and aboost to companies,” Warnery noted. strength in the US of anasal decongestant that ery pointed out. “Beyond the simple shifting of cost to cantreat allergy symptoms for afull 24 hours,” “The second reason is that the scope of patients,OTC products also improve the effi- Warnery said, “and we have had very good the therapeutic categories considered by the ciencyofthe system,”headded, “through the first results.” regulatory authority to be suitable for an OTC reduction in doctor visits, and faster access- Furthermore, Sanofiwas also on the look switch is much too narrow,”heargued.

10 OTC bulletin 27 June 2014 OTC27-06-14p8-14_Layout 1 26/06/2014 16:18 Page 5

AESGP MEETING OTC

While discussions with the European Medi- ings, restrictions on duration of treatment and Regulatory Af fairs cines Agency(EMA) were taking place, it had so on, Warnery pointed out. become clear,Warnery said, that there wasno However, these national conditions could Rasi recognises straightforward answer to the problems and a not be met in the single harmonised PI need- more nuanced approach would have to be taken. ed for acentralised switch, he claimed. Much “People are giving up on the centralised better would be the addition of ablue box on need for change authorised applications,”Warnery claimed, “so eachpack with space for the specific national we suggest agradual switch approach,where conditions, Warnery suggested. ou can mildly say that there is room we start with afew positive member states as Industry wanted to accelerate switch oppor- “Yfor improvement in the centralised pilot countries and afterwards we develop real tunities that made sense “from aconsumer health procedure approach,”according to Guido Rasi, life data to support the submission of the switch point of viewand acompanycommercialper- executive director of the European Medicines for all member states.” spective”, Warnery said, butthat would require Agency(EMA). “This could be agood wayofmaintaining “the regulatory environment to evolve, because Rasi admitted to delegates at the 50th centralisedswitch, especially for those countries clearly the systems needed to improve”ifthe Annual Meeting of the Association of the Euro- who don’tfeel ready for the switch,”headded. “triple win” wastobeachieved. pean Self-Medication Industry,the AESGP, that with only sevenOTC products having suc- Expand data protection cessfully navigated the centralised procedure Furthermore, data protection should be “ex- since its introduction nine years ago there was panded from one year to three years likeinthe “certainly room for improvement”. US to reflect the significant clinical studies Whycouldn’tprescription products that were worked on for the switch”, Warnery suggested. going through the centralised procedure be ear- “Another solution is improving information marked earlier in that process as potential OTC in the centralised procedure,”henoted. “Here, switch candidates in the future, Rasi suggested. we are facing aseries of hurdles which we should “Whydon’twesit down and have two overcome by working more closely with the paths: one for prescription and one for the relevant competent authorities.” additional requirements you might need to Asingle set of product information, or PI, Sanofi’s US subsidiaryChattem successfully switched makeitanOTC,”heargued. Nasacortinlate 2013 and launched the product earlier wasneeded when it came down to anational this year claiming it to be the only full prescription- There should be a“soft-ending” to amed- switch decision, which considered only asingle strength nasal allergy spray availableOTC in the US icine’sprescription status, Rasi said. country’sindication warnings, addiction warn- OTC OTC Sanofi relishing Cialis opportunity

cquiring the OTCrights to Eli Lilly’s to market Cialis OTCexclusively once regu- ingthe drug and waskey player in the global Aerectile dysfunction drug Cialis (tadala- latory approvalhas been granted. pharmaceuticals market. fil) represented a“fantastic opportunity” for If approved, Sanofianticipatedmarketing “It is an opportunity to launch anew cat- Sanofi, Vincent Warnery,senior vice-president Cialis OTCafter the “expiration of certain egory –which does not happen very often – of the French firm’sGlobal Consumer Health- patents”, the firm noted, adding that the terms agreat opportunity for the OTCbusiness care division, told delegates at the 50th An- of the agreement had not been disclosed. and Sanofi,”Warnery said. OTC nual Meeting of the Association of the Euro- Warnery pointed out that despite “massive pean Self-Medication Industry,the AESGP. efforts” on disease awareness and ‘ask your Expanding on the rationale for the deal – doctor’ campaigns the “vast majorityofmen” which wasannounced in May (OTC bulletin, still did not consult their doctor when suffer- 30 May 2014, page 1) –Warnery said that it ing from erectile dysfunction. wasattractive as there wasa“need to take However, what theydid do, he explained, care of acondition that affects millions of men wassearch online for products that theycould around the world”. access directly,and in doing so theyexposed themselves to the huge risk of counterfeiting. Need for reliable solution “60% of the medicines traded on the inter- “Furthermore, there is aneed for more net are fakesand when 30% of total online direct, yet responsible, access to areliable and sales are related to erectile dysfunction you legitimate solution to the condition,” he insisted. see the issue,”Warnery said. “Those are twocritical elements we must “The extent of this problem is pretty scary,” bear in mind,”Warnery said. Warnery insisted, “so with Cialis OTCSanofi Under the terms of the deal, Sanofihas ac- wouldoffer asafe and effective response.” quired from Lilly the exclusive rights to apply Cialis had already been used by over45 Vincent Warnery, senior vice-president of Sanofi’s for approvalofCialis OTCinAustralia, Can- million men around the world, he pointed out, Consumer Healthcaredivision, said Sanofi believed switching Cialis to OTC status would provide access ada, Europe and the US, as well as permission while Lilly had 12 years of experience market- to areliable solution for erectile dysfunction

27 June 2014 OTC bulletin 11 OTC27-06-14p8-14_Layout 1 26/06/2014 16:18 Page 6

OTC AESGP MEETING

ProductSafety Collaborationkey to consumer safety

ising abuse of OTCcough medicines in the safe. “Safety is at the top of consumers’ priority RUS had left industry in 2010 facing the list for their OTCmedicines,”she insisted. “real risk” of the products’ active ingredient Protecting consumers from unsafe medicines dextromethorphan being reverse-switched, Scott required a“common commitment” from all Melville, president and chief executive officer industry stakeholders, Raine stressed. Open dis- of the Consumer HealthcareProducts Associa- course within the industry when safety issues tion (CHPA), told delegates at arecent meeting emerged would maintain consumer trust in self- held by Europe’sself-medication industry. medication products. Noting that in 2009 around 5% of US teens Noting that industry needed to learn from had abused cough medicines, Melville ex- examples of successful risk mitigation, Raine plained howaninitiative coordinated by the highlighted tworecent cases from France and CHPA–which had brought together industry, the US of industry working proactively in col- regulatory bodies and consumers –had helped laboration with regulators, healthcare profes- to prevent the reverse-switch of dextromethor- sionals and consumers to address emerging Antoine Bon, vice-president of French industry association Afipa, called on industrytowork with phan by changing teen behaviour and reducing safety concerns related to OTCmedicines. consumers to build long-termtrust in OTC products incidences of abuse. In France, industry association Afipa had The effort had been “firmly grounded in worked with various stakeholders, Raine ex- and proper use of decongestants, Bon added. trust” between anumber of different stakehold- plained, to assess the risks of OTCdeconges- Describing the results of Afipa’sprogramme ers, Melville said, and had achieved“extremely tants and to promote the safe and proper use as “very satisfactory”, Bon told delegates that it positive results”. of the products. had encouraged “enhanced dialogue” between Melville introduced the CHPA’sinitiative at Presenting Afipa’sinitiative,the association’s industry and the ANSM. asession on building trust in OTCmedicines at vice-president, Antoine Bon told delegates how The proof of this increased collaboration, the 50th Annual Meeting of the Association of French industry had been faced with the poss- continued Bon, wasthe establishment of an the European Self-Medication Industry,the ibility in 2011 of decongestants being reverse- Afipa/ANSM joint committee on deconges- AESGP,inLondon, UK, which wasalso the switched due to safety concerns. tants. The committee also provided an “inform- 18th General Assembly of the World Self-Med- Bon pointed out that several pharmacovig- al platform” for industry to raise unrelated ication Industry (WSMI). ilance reports generated since 2000 had high- issues with the regulator,headded. lighted afew “exceptional” cases of cardio- Bon insisted that if industry opened up to Building consumer trust vascular and neurological adverse events related regulatory bodies, healthcare professionals and Chairing the session, Dr June Raine, director to the products. consumers, it could build long-term trust in self- of vigilance and risk management of medicines Coordinated by Afipa, industry had respond- medication products. at the UK’sMedicines and Healthcare products ed by creating acommittee to undertakeaben- Bon’sviews were echoed by the CHPA’s Regulatory Agency(MHRA), argued that the efit-risk analysis of decongestants using data Scott Melville, who called on industry to collab- “future success” of the self-medication industry provided by sevenmanufacturers, Bon said. orate with consumers and regulators when faced would “depend on building consumer trust in The committee had reported astable and with OTCproduct-safety issues. OTCproducts”. “very low” number of incidences each year Presenting the CHPA’sinitiative to tackle Raine told delegates that industry would since 2007 of adverse cardiovascular and neuro- teenage abuse of OTCcough medicines,Mel- earn this trust by ensuring its products were logical events to France’smedicines agency, ville told delegates that the programme had ad- ANSM, in 2012, Bon noted. dressed the potential reverse-switch of dextro- ANSM’sresponse to the findings, Bon ex- methorphan by changing teen attitudes towards plained, had been to commission an epidemio- medicines abuse. logical study of decongestants –the results of Responding to rising abuse rates, the US which are to be published in 2015 –incollab- Food and Drug Administration (FDA) in 2010 oration with 11 Afipa members. The Afipa-led had convened an advisory committeetocon- committee had pursued its owninitiative,Bon sider making dextromethorphan acontrolled said, to assist healthcare professionals to ensure substance, effectively reverse-switchingit. the safe sale of decongestants, including advis- ing consumers on howtouse the products. Launchedthree-partcampaign The initiative had offered over75% of Reacting to the FDA’sinterest in the issue, France’s22,000 pharmacists access to an e- the CHPAhad formed atask group of eight learning tool, Bon pointed out. The e-learning OTCcough medicine manufacturers, Melville site had included essential information on de- explained, and launched athree-partcampaign congestants for pharmacists to communicate to to tackle abuse rates and change teen behaviour. Industryneeded to learnfromexamples of successful consumers and rules for selling the products. The campaign had begun, continued Mel- risk mitigation, said Dr June Raine, director of vigilance and risk management of medicines at the UK’s Afipa had also produced an information leaf- ville, by working to increase parental aware- Medicines and Healthcareproducts RegulatoryAgency let for consumers, which detailed rules for safe ness of cough-medicine abuse through social

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AESGP MEETING OTC

media and by educating community leaders appearing to glamourise medicines abuse, but about the problem. instead had addressed the risks and conse- Alongside parental education, the campaign quences of such behaviour. had addressed the accessibility to teens of OTC Over atwo-year period, around 10 million cough medicines, Melville said. Industry had teens had viewed the campaign videos or shared sought “formal restrictions” on teens’ ability to the material with their friends, Melville noted. purchase the products, and six US states had Industry should takeadvantage of social passed laws to ban sales to consumers aged media, he advised, as it could better target under 18 years. consumers compared to traditional forms of Finally,the campaign had targeted teens communication. directlyonsocial-media websites likeFace- Turning to the results of the campaign, book and YouTube, Melville noted. By utilis- Melville said it had helped to push down cough- ing social-media listening tools, campaign rep- medicine abuse rates to the lowest levelsince

resentativeshad responded to online conver- the CHPAhad begun tracking them, with a20% Scott Melville, president and chief executive officer of sations about cough-medicine abuse with com- decline since 2010. In addition, asurvey con- the Consumer HealthcareProducts Association (CHPA), ments challenging the behaviour in an “auth- ducted by the CHPAhad shown that eight out argued that industryshould communicate regularly with regulators when tackling drug-safety issues entic peer-to-peer tone”. The purpose of these of nine teens believedthat cough-medicine targeted responses had been to “change the abuse washarmful. mitment to tackling the problem, he added. conversation”, Melville pointed out, and to in- Moreover, the National Institute on Drug Melville insisted that industry should com- crease teen awareness of the “physical risks Abuse’s(NIDA’s) Monitoring the Future survey municate regularly with regulatory bodies when and social disapproval” associated with cough- reported that cough-medicine abuse “continued tackling drug-safety issues. “Involveregulators medicine abuse. to decline” in the US (OTC bulletin,17Jan- in the process, tell them what you are doing and uary 2014, page 10). share the results with them,”herecommended. Created ‘Trojan horse’ videos Throughout the campaign, the CHPAhad The campaign had shown that it wasbene- Noting that teens often posted videos of regularly met with the FDAand other govern- ficial for industry to work together when facing themselves abusing cough medicine on You- ment agencies to brief them on the progress acommon problem, Melville maintained. “It Tube, Melville explained that the campaign of the programme and to seek input, Melville makes no sense for one companytotackle had responded by creating ‘Trojan horse’ said. This direct communication with the reg- safety issues alone,”hesaid, “when the whole videos. These videos had attracted teens by ulator had helped to reinforce industry’scom- industry suffers the same consequences.” OTC

27 June 2014 OTC bulletin 13 OTC27-06-14p8-14_Layout 1 26/06/2014 16:18 Page 8

OTC AESGP MEETING

Regulatory Af fairs ANEFPspeeds up marketing endorsement

panish OTCcompanies can nowhavetheir Sadvertising campaigns approvedwithin sevendays as part of the self-regulatory system set up by the Spanish self-medication associ- ation (ANEFP), according to its executive dir- ector Jaume PeySanahuja. Previously,the pre-clearance process for advertising approvalthrough the Ministry of Health had taken amonth and ahalf on aver- age to complete, he told delegates at the 50th Annual Meeting of the Association of the Euro- pean Self-Medication Industry,the AESGP, in London, UK. The ANEFP Seal has been created as away of ANEFP’s executive director,Jaume Pey Sanahuja, said This wasjust one of the improvements that continuing quality control and compliance with the the introduction of the Seal had led to apredictable current advertising rules model and greater flexibility in assessment criteria had been made to regulating OTCadvertising in Spain, continued Sanahuja, to produce a address and the serial number and year of ap- Assessments of applications for an ANEFP “more efficient and productive advertising mod- proval, the Seal is also said to represent the Seal were carried out by the association’sTech- el” and increase the value of self-care amongst commitment of the pharmaceutical industry to nicalDepartment, Sanahuja said, with the assist- stakeholders. These changes had been put in responsible advertising. The associationaimed ance of an official from the Ministry of Health. place following removalofthe previous pub- to be a“leading reference point for quality in- The Seal wasalso available to non-members lic advertising control (CPS) in July last year. formation”, Sanahuja added. of ANEFP,henoted. Companies could nowalso refer to the flav- “[The introduction of the Seal] has led to a Advertisements failing to be granted the Seal our and smell of their OTCproducts in adver- predictable model and greater flexibility for the could either go to market without it, Sana- tising, Sanahuja explained. This had previously assessment criteria,”hepointed out. huja explained, or firms could seek arbitration been forbidden in the CPS, which had been in Companies that were granted use of the through the Spanish advertising self-regula- place since 1985. OTCbrands were also permit- Seal could choose to include it in their print tion body,Autocontrol. ted to sponsor television programmes, he added. and television advertisements, Sanahuja ex- Furthermore, the ANEFP Seal had been plained, butits use wasnot mandatory under 86% of applicants granted aSeal created as away of continuing quality control Spain’snew advertising rules. However, thanks to the improvedflexibility, and compliance with the current advertising These were based on current Spanish and efficiencyand consistencyofthe newsystem, rules, Sanahujamaintained. ANEFP wasaim- European legislation, Sanahuja pointed out, as Sanahuja pointed out that 86% –673 –ofthe ing for the Seal to be recognised by all stake- well as the advertising guidelines previously 784 campaigns submitted between August 2013 holders, including doctors, pharmacists and agreed with the Ministry of Health. ANEFP also and April this year had been granted aSeal. consumers, as asign of advertising that had took into consideration the latest authorised ANEFP is also currently negotiating with been vetted by the association and wasinline Summary of Product Characteristics (SmPC) health authorities to obtain recognition of its with the current legislation. of the product for which the application had self-regulatory process, with aco-operation Featuring the organisation’slogo, website been submitted. agreement soon set to be signed between ANEFP,the Ministry of Health and Autocontrol. “In the past, our fate wasinthe hands of others,”Sanahuja told delegates. “Now, we are The 51st AESGP Annual Meeting the owners of our fate.” Hilton DiagonalMar Hotel, Barcelona, Spain Roger Scarlett-Smith, president of Glaxo- 26-28 May 2015 SmithKline Consumer Healthcare Europe, com- mended the system, commenting that the Span- Forfurther detailsemail [email protected] ish economy needed “free and empowering reg- ulation to enable free competition and to create aforward momentum”. This sentiment wasechoed by Briain De Buitleir,chief executive officer of PGT Health- care, the joint venture between Procter & Gamble and Teva.The process wasa“great demonstration” of howcollaboration between industry,regulators and other stakeholders could be “truly brought to life in avery positive way”, he commented. OTC

14 OTC bulletin 27 June 2014 OTC27-06-14p15-17_Layout 1 26/06/2014 16:22 Page 2

MARKETING NEWS OTC

AdvertisingComplaints ProductLaunches/LineExtensions Westport can Sanofi adds Icy Hot to its support claims Dorflex portfolio in Brazil estport Pharmaceuticals can support its Wclaims that its Zephrex-D pseudoephe- anofihas expanded the reach of its IcyHot drine nasal decongestant tablets provide “fast, Sheat-relief products in South America with effective relief”, start working to clear swollen the launch of four variants in Brazil under its nasal passages in “as little as 30 minutes” Dorflex analgesic brand umbrella. and maintain “full efficacy” for the duration of Targeted at “all people suffering from mus- the dosing period, the US’ National Advertis- cle aches that affect their daily lives” – with ing Division (NAD) has ruled. aparticular focus on amateur and professional Acura Pharmaceuticals, manufacturers of the athletes –the DorflexIcy Hot range comprises rivalNexafed product, complained to the reg- a spray and roll-on liquid, as well as an elas- ulator about Westport’sclaims, which appeared tic bandage. There is also a pain-relief patch Sanofi says the introduction of Icy Hot into major in television, print and online advertising. The variant, which is available in small, large and pharmacy networks throughout Brazil will be bolstered by the “strength and tradition” of the Dorflex name firm argued that the formulation of Zephrex- extra large sizes. All products contain menthol. D, which is said to use technology that pre- Pointing out that Dorflexwas the best-sell- America has so farbeen small, with the range vents the extraction of pseudoephedrine for use ing OTC pain-relief brand in the Brazilian only marketed in Mexico. The elastic bandage in the production of the drug ‘crystal meth’, pharmaceutical market according to IMS fig- and extra-large adhesive were exclusive to reduced its therapeutic efficacy. ures, Sanofisaid the introduction of IcyHot into Brazil in the South American market, noted Although Westport had provided no direct major pharmacy networks throughout Brazil Sanofi, which gained the IcyHot brand when clinical relief studies to support the 30-minute would be bolstered by the “strength and tradi- it acquired US firm Chattem for US$1.9 bil- claim, NADnoted, the firm supplied evidence tion” of the Dorflexname. The firm added that lion (C1.4 billion) in 2010 (OTC bulletin,17 regarding the bioavailability of the product. the launch would cater for an “unmet consumer March 2010, page 9). This evidence “reliably demonstrated” that need for topical products” in the market. Atelevision campaign and advertisements within 30 minutes of dosing, Zephrex-D would Until now, the Dorflexline has consisted of in sports magazines will support the launch. reach blood levels associated with the onset of tablets and drops –containing orphenadrine and Sanofi also plans to increase the relevance of action, NADadded, and that these levels would dipyrone – that are indicated for the relief of the brand among younger audiences through remain within the range classed as having the muscle pain and tension headaches. the creation of Facebook and Twitter profiles, “maximum effect” for the duration of the dos- While the Icy Hot products are available as well as awebsite. The firm will also target ing period, thus maintaining “full efficacy”. in more than 30 countries, penetration in South healthcare practitioners. OTC OTC

ProductLaunches Australian Guild extends Gold Cross line

he Pharmacy Guild of Australia has ex- outlets and changes to government pricing Ttended its Gold Cross pharmacy-exclu- policies, the Guild pointed out. sive product range with the addition of OTC Furthermore, adecongestant nasal spray and variants for cold and flu, pain-relief and diges- pain-relief tablets are set to be added in August tive health. to the line, which was previously comprised Thornton & Ross is looking to “facilitate even better Launched this month, the latest additions primarily of traditional family health remedies communication with pharmacists and pharmacy –which include ibuprofen tablets, diarrhoea- such as calamine lotion and castor oil. assistants” with the launch of a trade website for its Care healthcare brand. relief tablets and cough suspensions –had been A proportion of sales would go “directly Claiming that one Care product was sold every created in response to the “continued pres- to fund the Guild’s actions in promoting the second of the pharmacy working day, the firm sures” on community pharmacyfrom grocery future and value of pharmacy”, the organisa- highlighted that the allthecareyouneedhcp.co.uk website would raise awareness of Care’s “corevalues of tion pointed out. trust, efficacy and value for money” by providing product Developed with the Guild’s strategic part- information, training and advice on pharmacy issues. ners–local pharmaceutical companies iNova The 90-strong Careproduct line had been divided into nine categories to help educate pharmacy staff about and Probiotec – the range will be distributed the entire Care range and enable them more easily to through Australian pharmacywholesalers API, recommend products to consumers, noted Thornton & Sigma and Symbion. Ross, which was acquired by German firm Stada in August last year (OTC bulletin, 23 August 2013, The products’ packaging features the Guild’s page 1). These categories include: cough and colds; gold cross logo, which is said to be a “sym- A proportion of Gold Cross sales will go “directly to digestive health; pain relief; and hayfever and allergies. bol of community trust and care”. OTC fund the Guild’s actions in promoting the future and value of pharmacy” OTC

27 June 2014 OTC bulletin 15 OTC27-06-14p15-17_Layout 1 26/06/2014 16:22 Page 3

OTC MARKETING NEWS

AdvertisingComplaints MarketingCampaigns Biocalth claims J&J airs Sinutab creative banned by ASA for South African winter Kfirm Principle Healthcare made unauth- Uorised health claims and disease-risk re- man with an unnaturally large head due duction claims in online advertising for its Bio- Ato congestion is the focus of Johnson & calth calcium supplement, the UK’sAdvertising Johnson South Africa’stelevision campaign for Standards Authority (ASA) has ruled. These its Sinutab Nasal Spray. must not appear again in their current form. Launched in time for the winter season, the The firm was also warned that it must not 30-second creative for the pharmacy-only spray, make general efficacyclaims in the absence of containing 0.1% w/v xylometazoline, features adequate substantiation. aman struggling to complete daily tasks cor- Only health claims listed as authorised on rectly because he has ahead cold, which makes The television spot for the Sinutab Nasal Spray in the European Union (EU) Register of Nutrition his head feel larger than normal. He is shown South Africa shows a man struggling to complete simple daily tasks because his head is congested and Health Claims made on foods were permit- making simple mistakes such as picking up a ted in advertising, the watchdog pointed out. stapler instead of a phone at work, and pour- up to 10 hours. Consumers are also encour- The watchdog investigated a total of 11 ing orange juice on his breakfast plate instead aged to talk to their pharmacist about which claims. These included that the product im- of in a glass. product from the Sinutab range is best for them. proved bone density and encouraged the for- “When your nose is blocked, pressure starts Other variants include allergy tablets, as well mulation of cartilage and collagen, and that it to build, making your head feel heavy,” avoice- as asaline nasal spray that can be purchased could prevent osteoporosis. over points out, noting that congestion can outside of pharmacies. Principle Healthcare had also stated that the “make it hard to think straight”. The campaign, which the firm said would product contained calcium L-threonate, which The spot also highlights that the spray re- run “indefinitely”, is being supported further increased the absorption rate of calcium to “a lieves the pressure and clears the head cold by radio promotion and print advertisements, massive 95%, compared to 40% in ordinary within 10 minutes, and that the effects last for as well as point-of-sale materials. calcium supplements”, and that calcium L-thre- OTC onate passed through the intestine more quick- ly than any other calcium supplement. These were health claims with acompar- ative element, the ASA noted.

No evidence of authorised claims Despite the firm providing the watchdog with a number of studies – including a Euro- pean Food Standards Authority (EFSA) Opin- ion on the bioavailability and safety of L- threonate as asource of calcium in food supplements –the ASA said it had not seen evi- dence that the claims made were authorised on the EU Register. The EFSA study did not refer to the assess- Beauty from within is the promise in launch trade-press ment of the health claims, the ASA pointed out, advertising for the latest additions to Queisser Pharma’s Doppelherz System range of pharmacy-exclusive nor did it compare Principle Healthcare’sprod- supplements in Germany. uct with other forms of calcium. Therefore, Doppelherz System Haut Plus promises to deliver there wasnoevidence to showthat the compar- “healthy skin” through its combination of tablets containing biotin, silica, zinc and vitamins along with ative claims were authorised, or listed as sep- capsules that provide nutrients such as avocado oil arate authorised claims. and lycopene. Furthermore, as most of the other studies Presented as tablets, DoppelherzSystem Haar Plus “Herpes in the city?” is the slogan that HRA Pharma submitted had not been conducted on humans, provides biotin to help retain hair, copper to protect is using to draw attention to its newly-launched Clareva its colour and zinc to strengthen nails. Also among a gel in French pharmacy-press advertising for the product. the comparative claims were misleading. total of 17 nutrients are field horsetail and taurine. Clareva –which forms an “invisible protective film” There was also no evidence that Principle A month’s supply of either supplement has a containing oxidised triglycerides from essential fatty Healthcare’sdisease-risk reduction claim was recommended retail price of C14.95. acids – “rapidly soothes pain from the first day” of Meanwhile, Queisser has also extended the use, according to the advertisement. authorised on the EU Register. The firm had pharmacy-exclusive range with Doppelherz System Clinical trials demonstrate that pain linked with claimed that Biocalth wasscientifically proven Antarktis Krill, which provides omega-3oils from 1,000mg genital herpes falls by 61% from the first day of using to prevent the slowing down of bone renewal, pureAntarctic krill oil. Apack of 60 two-a-day capsules Clareva, HRA Pharma claims, also suggesting that it – that also contain calcium and vitamins B1 and D3 – is almost completely eliminated after eight days. The which could lead to osteoporosis. has a recommended retail price of C29.95. odourless, paraben-free gel is available in a 10g tube. OTC OTC OTC

16 OTC bulletin 27 June 2014 OTC27-06-14p15-17_Layout 1 26/06/2014 16:22 Page 4

MARKETING NEWS OTC

Marketing Campaigns Flen Pharma stickers aim to help reduce burn risk

eatsensitive stickers that change colour Hto show when an object is too hot to touch are on offer to consumers who purchase Bel- gian firm Flen Pharma’s Flamigel wound-heal- ing gel. Through its latest promotion, the com- pany aims to highlight how the brand can help to prevent burns, as well as treat them. Reckitt Benckiser (RB) is continuing its ‘Intimate Sessions’ theme for its Durex condom brand by Claiming that 120,000 people suffered burn offering UK consumers the chance to win music-related injuries in its domestic market each year, Flen prizes when they purchase special packs. Pharma noted that over half of the victims were To be eligible to win prizes such as festival tickets, Stickers that change from blue to red will signal iTunes vouchers and gift cards for concert-ticket children, because they were “often unaware of to children that an object is too hot to touch. retailer Ticketmaster, consumers need to purchase a the dangers lurking in and around the house”. Flen Pharma hopes that this will prevent burns pack from either Boots or Superdrug stores. They must then enter their personal details and the on-pack code on the dedicated Intimate Sessions website, “Ominous” faces signal danger book, Twitter and business social network Yam- durexintimatesessions.co.uk. The competition will When stuck on objects that heated up to mer – as well as on the Flamigel website and run throughout the year. over 40 degrees celsius, such as kettles, the Flen Pharma’s wound-care information web- Thanks to previous Intimate Sessions promotions, which invite consumers to “get closer to the music – faces on the ‘Hot or Not’ stickers changed from site hoebehandelik.be. Pharmacists are also and each other”, there had been a “positive shift” blue to “red, ominous figures” that signalled being provided with in-store materials. in the way that consumers valued the brand, RB danger, the firm pointed out. Each 100g pack of Although the gel is available in other mar- claimed. Last year, Durex partnered with Microsoft’s internet portal MSN, music magazine NME and the medical-device gel contains two stickers. kets such as China and Germany, the offer is music-streaming service Spotify to give away pairs Expected to run until the end of July, the in- exclusive to the Belgian market, where Flamigel of tickets to see “big-name acts in small locations” centive is also being promoted via the com- is said by Flen Pharma to hold the number-one around the country as part of the campaign (OTC bulletin, 23 August 2013, page 22). pany’s social-media platforms – including Face- position in the wound-healing category. OTC OTC

Repackaging Bion 3 packaging is refreshed in Russia ussia is the latest market to see updated Rpackaging for Merck KGaA’s Bion 3pro- biotic multivitamin/multimineral supplements. Forest Laboratories’ Sudocrem nappy-rash brand is Refreshing the look of both the Bion 3and running a “Nappy Changing Challenge” as part of its sponsorship of recently-launched parenting website Bion 3 Kids variants was part of a “global Up All Hours. branding scheme” launched three years ago, The video challenge – which is shown on the Indian firm Dr Reddy’s, which licenses the website and the Up All Hours YouTube channel – pits contestants such as celebrity chef Jamie Oliver Bion 3brand in the country,told OTC bulletin. against the clock, to change a child’s nappy using This packaging can already be seen in markets Sudocrem’s “Clean, Dry and Apply” three-step such as France and the UK, where the brand is process and its Care & Protect cream. Through the partnership, the firm said it aimed to “reinforce known as Multibionta. Sudocrem’s credentials as a caring brand”. The light-blue-and-orange boxes – which OTC are being phased into pharmacies overthe next three-to-four months – reflected the brand’s position in the premium segment of Russia’s IN BRIEF vitamins, minerals and supplements (VMS) ■ EXPOSURE to television advertisements market, the firm added, and were intended to The refreshed packaging for Bion 3 is intended to for e-cigarettes among those in the US aged increase its appeal to the target female audience. reflect its position within the premium segment of the Russian VMS market and make the product line more between 12 and 17 years grewbyover250% The larger size and horizontal shape meant appealing to women between 2011 and 2013, according to astudy that the products would also be more visible on published in the journal Paediatrics.Exposure pharmacy shelves, Dr Reddy’s noted. uct – which is said to strengthen the immune among those between 18 and 24 years rose Advertisements in trade-press and women’s system – remain the same. more quickly by 321% overthe same period. consumer titles highlight that while the pack- There will also be point-of-sale materials. OTC aging has changed, the benefits of the prod- OTC

27 June 2014 OTC bulletin 17 Deals Database...News...News Extras...Briefings... Reports...Events...Useful Contacts

Essential Business Development Tools For The OTC Industry

The OTCToolbox website gives OTC decision-makers worldwide immediate online access to authoritative business development tools. Our information services – Deals Database, News, News Extras, Briefings, Reports, OTCRESULTS Events and Useful Contacts –can help you... COMPARISONS Mixedstrategies producemixed results

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3June 2014 OTC RESULTS Analyse COMPARISONS Mixed strategies produce mixed results

Acquisitions, prescription-to-OTC switching and emerging markets all featured prominently in the recent financial results of branded OTC players. Furthermore, manufacturing problems continued to make thepast… their presence felt, as recalls and relaunches influenced fortunes. The end result was amixed bag of financial results for key OTC businesses worldwide.

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This newBRIEFINGfrom Deliver OTCToolbox is designed to provideyou with an easy way to compare therecentfinancial resultsofleading OTCbusinesses thefuture worldwide. Around 60 pageslong, it covers financial resultsreported by selected brandedOTC players in 2013 andthe first quarterof2014. Keyindustrytrendsare identified in afeature article,while selected OTCbusinesses arecovered in more detail in individual Think Inside The Box company resultsprofiles. JUST Visit www.OTCToolbox.com PUBLISHED

ToolboxA4dealsadvert130614.indd 1 16/06/2014 09:59 OTC27-06-14p19Events_Layout 1 26/06/2014 15:36 Page 2

EVENTS OTC

Email: [email protected]. AUGUST 7-8October Website: www.topra.org. AESGP Conference 14 August ■ Brussels,Belgium 21-22 October ■ Basics of ‘Herbal (medicinal) products, food supplements and self-care medical Maximise Self-Care Pharmaceutical ■ devices: Paving the waytowards acoherent system’ is the theme of this Potential RegulatoryAffairs two-day event run by the Association of the European Self-Medication Phuket,Thailand London, UK Industry,the AESGP. The 10th World-Self Medication Aone-day meeting run by The There will be sessions on: ‘Finding the right balance for herbal (med- Industry (WSMI) Asia-Pacific Organisation for Professionals in icinal) products, food supplements and self-care medical devices’; ‘Ensur- Conference will form part of this Regulatory Affairs (TOPRA). ing the right assessment of food supplements and health claims’; and two-day event. Contact:TOPRA. ‘Adjusting the medical device legislation to consumer needs’. Contact:Thai Self-Medication Tel: +44 20 7510 2560. Speakers will include: Basil Mathioudakis and Paola Testori Coggi of Industry Association (TSMIA). Fax: +44 20 7537 2003. the European Commission; Werner Knöss of the Committee on Herbal Tel: +33 450 28 47 28. Email: [email protected]. Medicinal Products (HMPC); and Ioanna Chinou of the European Med- Fax: +33 450 28 40 24. Website: www.topra.org. icines Agency(EMA). Email: [email protected]. Contact:AESGP.Tel: +32 2735 51 30. Fax: +32 2735 52 22. 21-22 August Website: www.tsmia.or.th. Email: [email protected]: www.aesgp.eu/events/Brussels2014/. ■ Marketing Authorisation in Russia/CIS countries NOVEMBER Tel: +49 6221 500 680. Contact:Management Forum. Berlin,Germany Fax: +49 6221 500 555. Tel: +44 1483 730071. 5-8November Countries to be covered at this two- Email: [email protected]. Fax: +44 1483 730008. ■ CRN’s Annual daymeeting will include Belarus, Website: www.forum-institut.com. Email: registrations@management- Symposium for the Kazakhstan, Russia and Ukraine. forum.co.uk. DietarySupplement Contact:Forum Institut 3-4September Website: www.management-forum.co.uk. Industry für Management. ■ Vitafoods Asia Tel: +49 6221 500 680. Hong Kong OCTOBER California, US Fax: +49 6221 500 555. This two-day exhibition and con- Afour-day conference organised Email: [email protected]. ference claims to be Asia’sonly 6October by the US Council for Responsi- ble Nutrition (CRN). Website: www.forum-institut.com. dedicated nutraceutical event. ■ Marketing Authorisation Contact:Informa Exhibitions. in the Middle East Contact:CRN. 26-29 August Tel: +1 202 204 7700. Tel: +44 20 7551 9785. Frankfurt, Germany Fax: +1 202 204 7701. ■ Pharma Marketing Asia Fax: +44 20 7017 7818. This one-day seminar will focus Email: [email protected]. Singapore Email: [email protected]. on market entry in the Middle East. Afour-day event that claims to be Website: www.crnusa.org. Website: www.vitafoodsasia.com. Contact:Forum Institut für the region’sonly platform to pro- Management. vide up-to-date and in-depth eval- 16 September 13-14 November Tel: +49 6221 500 680. uations of marketing strategiesfor ■ Mutual Recognition ■ 9th International Fax: +49 6221 500 555. prescription and OTCproducts. Alliance Conference and Decentralised Email: [email protected]. Contact: IBC Life Sciences. Berlin,Germany Procedure Website: www.forum-institut.com. Tel: +65 6508 2401. Bonn, Germany This two-day meeting will bring Fax: +65 6508 2407. Practical exercises will give dele- 7October together manufacturers, outsource Email: [email protected]. gates the opportunity to assess their ■ Global Generics & sales and marketing service provid- Website: www.pharmaconasia.com. ownregulatory strategy. Biosimilars Awards 2014 ers (distributors) and industry opin- Contact:Forum Institut für Management. Paris,France ion leaders in health and beauty. 27-29 August Tel: +49 6221 500 680. These newAwards will recognise Contact:Ceuta Healthcare. ■ Introduction to European Fax: +49 6221 500 555. the achievements of the global gen- Tel: +44 1202 449 709. RegulatoryAffairs Email: [email protected]. erics and biosimilars industries. Email: lorian.pitman@ceuta London, UK Website: www.forum-institut.com. Organised by Generics bulletin, healthcare.com. This three-day meeting will look theywill reward business develop- Website: www.ceutaalliance.com/ at medicine registration require- 22-23 September ment initiatives, cleverlicensing 2014_conference_berlin.html. ments and procedures. ■ China: RegulatoryAffairs deals and smart legalmanoeuvres. 17-18 November Contact:Informa UK. for Pharmaceuticals Contact: Generics bulletin. EuroPLX 56 Tel: +44 20 7017 7481. London, UK Tel: +44 1564 777 550. ■ Nice,France Fax: +44 20 7017 7823. Variations, registration and renew- Fax: +44 1564 777 524. This two-day conference will pro- Email: [email protected]. als in China will be discussed. Email: natalie.cornwell@generics- vide aforum for business devel- Website: www.pti-global.co.uk/ Contact:Informa UK. bulletin.com. opment decision makers for dis- euregaffairs. Tel: +44 20 7017 7481. Website: www.generics-bulletin.com. Fax: +44 20 7017 7823. cussing and negotiating collabor- SEPTEMBER Email: [email protected]. 13-15 October ative agreements in licensing, mar- Website: www.pti-global.co.uk. ■ 11th TOPRA keting, and distribution of patented 2September Annual Symposium medicines, generics, biosimilars, ■ Marketing Authorisation 24-26 September Brussels,Belgium OTCproducts, medical devices in the Balkan States ■ Advanced Athree-day event run by The Org- and food supplements. Frankfurt, Germany Pharmacovigilance anisation for Professionals in Reg- Contact:RauCon. Albania, Kosovo,Macedonia and London, UK ulatory Affairs (TOPRA). Tel: +49 6222 9807 0. Serbia will be among countries to Athree-day course that will cover Contact:TOPRA. Fax: +49 6222 9807 77. be covered at this one-day seminar. the main regulations required un- Tel: +44 20 7510 2560. Email: [email protected]. Contact:Forum Institut für Management. der newEuropean legislation. Fax: +44 20 7537 2003. Website: www.europlx.com.

27 June 2014 OTC bulletin 19 OTC27-06-14p20-23_Layout 1 26/06/2014 15:57 Page 2

OTC AESGP MEETING Innovation key to driving OTC market

While the consumer healthcare industry accepts that innovation is key todriving not adding huge benefits to the consumer”. growth, it needs to think bigger and focus more on what the consumer wants “I think industry is doing anumber of things to innovate, butdoes it need to be thinking of and is prepared to pay, according to IMS’ Andy Tisman. Matt Stewart reports. the bigger picture and driving more meaning- ful innovation to the consumer?” he asked. nnovation in the consumer healthcare with additional benefits for which consumers Other sectors, including the fast-moving con- space needs to be about “big, bold ad- are willing to pay more money is really key,” sumer goods (FMCG) and consumer packaged vances and not so much about tinkering he insisted. goods industries, could provide models for suc- Iaround the edges”, according to Andy Tis- “When we look at the growth drivers in cessful innovation, Tisman noted, as theyrolled man, senior principal, consumer health at mar- the past five years, taking Europe as an ex- out simple advances – such as in dosing and ket researcher IMS Health. ample, innovation really does drive all the delivery technologies –that added benefits for Speaking to delegates at the 50th Annual growth in the market place,”Tisman explained. the consumer and increased margins through Meeting of the Association of the European a slightly higher price point. Self-Medication Industry,the AESGP in Lon- Innovation drives growth It wasalso clear,Tisman explained, that due don, UK, Tisman said that while it wasobvious Growth of almost a quarter in the Euro- to global diversity there was not a “one-size- industry “recognised the need for innovation”, pean OTC market in the past five years had fits-all” approach to innovation. the question was: howwell does it innovate and come from innovation, Tisman noted, with 17% “Europe alone is 30-40 different countries, do these innovations impact the consumer? of the growth coming from line extensions and Latin America 15-20, Asia-Pacific is manycoun- “Innovation is key as most of the volume 7% from new products (see Figure 2). tries and there is ahuge diversity of consumers growth in the market is pretty limited,” Tis- However, the figures in Europe offered a there,” he pointed out. man pointed out. “The majority of growth in warning to industry, Tisman said. “We count “So, while we need to think about break- the developing world in many cases comes innovations as all the new products and line through innovation, we also need to think about fromvalue growth rather than volume growth” extensions,”he pointed out. “In fact, the major- what is right for each country,” Tisman said, (see Figure 1). ity of innovation we coverhere comes from line “and it is probably true that aone-size-fits-all “So innovating to provide better products extensions, which by definition are probably approach probably isn’t going to work.” Looking at the European market more close- Volume growth Value growth ly,Tisman said that in the region newproducts –defined as products launched in the past two 20 15.7 16.0 years – accounted for 4% of the OTC market 15 in value terms in 2013, with contribution vary- World Growth 10.9 ing between countries. Volume: 3.4% 10 8.9 In Belgium and Switzerland, Tisman point- Value: 8.1% 6.4 6.7 4.3 ed out, new products took just a 2% share of 5 3.5 the market, while in Poland this increased to Change (%) 1.6 0.6 0 8% (see Figure 3). -0.3 What wasalso interesting, he noted, wasthe -1.1 -2.1 -2.1 -5 “inverse relationship” between the “average Japan North Western EMEA* Central and APAC** Latin America America Europe Eastern Europe * Europe, the Middle East and Africa ** Asia-Pacific, excluding Japan Base value growth Price increase Line extensions New products Figure 1: OTC growth in both volume and value terms broken down by key regions worldwide in 2013 (Source –IMS OTC Global Analysis) 80

12 10 60 8 29 8 7 40 6 7 5 6 20 17 4 4 Change (%) 31 4 13 3 3 13 6 22 0 2 -12 -15 New products share (%) -6 0 -10 Central and Europe Western Italy UK Eastern Europe Europe Poland Spain Russia France Germany Belgium Switzerland Figure 2: Breakdown of contribution to growth Figure 3: Share of the OTC market in various European countries obtained by new products in 2013 based on five year sales from 2009 to 2013 (Source –IMS OTC Global Analysis) (Source –IMS Elements of Growth)

20 OTC bulletin 27 June 2014 OTC27-06-14p20-23_Layout 1 26/06/2014 15:57 Page 3

AESGP MEETING OTC

VMS* 6 VMS* 21

Pain relief 4 Pain relief 37

Cough, cold 4 Cough, cold 79 & respiratory & respiratory

Digestives 4 Digestives 99

Skincare 3 Skincare 142

02468 050100 150 Change (%) Change (%) * Vitamins, minerals and supplements * Vitamins, minerals and supplements

Figure 4: Growth of value share of new products Figure 5: Price premium of new products across across key European OTC categories in 2013 key European OTC categories in 2013 (Source –IMS OTC Global Analysis) (Source –IMS OTC Global Analysis)

Pharma growth OTC growth Andy Tisman, senior principal, consumer health at IMS Health, called for industry to embrace “big, bold 9.5 advances” in product development 10

7.6 8 7.4 7.5 7.2 price premium for innovation” and the contri- 7.2 7.2 6.9 6.7 6.7 6.8 bution innovation wasmaking to the category. 6.2 5.6 6 “The vitamins, minerals and supplements 5.0 5.1 4.7 4.4 4.6 4.6 (VMS) category, which has the lowest price 3.9 4 3.2

premium for newproducts, also has the highest Change (%) 2.6

contribution from new products,” Tisman ex- 2 plained, “whereas skincare is the other way round (see Figures 4 and 5).” 0 “Is this telling us something about the need 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013

to get the right balance with innovation be- Figure 6: Value sales growth in the global pharmaceutical and OTC market over the past 11 years tween the benefits and the price we are asking (Source –IMS OTC Global Analysis) the consumer to pay?” he asked. Furthermore, innovation should be about including Sanofi’s Allegra Allergy, Procter & Cough, cold, respiratory Total OTC more than just product development, Tisman Gamble’s Prilosec and Johnson & Johnson’s 5 2.6 said. Social media was now “ever present in Zyrtec – were recent prescription-to-OTC 0.6 consumers’ daily lives”, he pointed out, but switches, Tisman said, accounting for 9% of 0 needed to be used better by consumer health- total OTC sales in the country. care companies. It was a similar picture in Europe, Tisman -1.2 -1.5 Meanwhile, healthcare apps were growing added, with switch products accounting for -5 rapidly, with cardio, diet and women’s health eight of the top-20 OTC brands and 6% of apps accounting for half of the volume, Tisman total OTC sales. Change (%) -7.4 added. Devices designed to improve efficacy Historically there had been quite a“strong -10 and control were becoming more common and focus on switching within traditional OTC ‘wearable tech’ products gave consumers dir- categories”, such as pain relief and digestion, -12.4 -15 ect feedback on the current state of their health. Tisman noted, butthis wasstarting to change. Latest Latest Latest moving “Science is important and will continue to “We’ve seen things like GlaxoSmithKline’s quarter six months annual target be so, butthere are manyother aspects to con- weight-loss drug Alli,”Tisman said, “like Merck Figure 7: Sales development in the cough, cold, sider in this ‘techno’ age –which includes digi- &Co’sOxytrol for Women –which created respiratory category and the total OTC market tal, devices, and manyother ways of engaging the new OTC treatment category in the US of across 14 European countries as of March 2014 (Source –IMS Pharma Trend International) with the consumer –apart from just tweaking overactive bladder in women – and of course the product formulation,” Tisman said. the announcement of Sanofi’splan to switch to get the product into the OTC marketplace. Despite the growth of newareas of innova- erectile dysfunction drug Cialis”(OTC bulletin, Although the innovation potential of the tion, one area continued to provide “big, game- 30 May 2014, page 1). OTC space could be exploited better, growth changing innovation in OTC” and that was in the global OTC market continued to out- switching, Tisman admitted. Huge interest in Cialis pace that of the total pharmaceuticals sector, “It has been abig driverofgrowth overthe There would be huge interest in the Cialis Tisman said. years,” Tisman pointed out, “and the path to switch, Tisman predicted, as it waspublic know- Looking at value sales for the calendar year switch in both North America and Europe is ledge that Pfizer had looked at the erectile 2013, Tisman pointed out that the OTCmarket well established.” dysfunction category in the past with Viagra. had moved forward by 7.2% compared to the In the US, six of the top-10 OTC brands – So far, Tisman noted, Pfizer had not been able 4.6% growth in the worldwide pharmaceutical

27 June 2014 OTC bulletin 21 OTC27-06-14p20-23_Layout 1 27/06/2014 08:51 Page 4

OTC AESGP MEETING

market overall (see Figure 6onpage 21). 30 OTCsales of C86 billion accounted for China 12.3% of aglobal pharmaceuticals industry worth C701 billion in 2013, he added. 25 However, this big advance in 2013 had been drivenbyastrong end to the 2012/ 20 2013 cough and cold season, Tisman said, warn- Latin America

ar Change (%) Central

ing that the full 2013/2014winter period had Ye 15 and Eastern been significantly weaker. Global Europe South Asia Drawing on figures from 14 European coun- Latest 10 Western tries, Tisman said that in “the whole 2013/2014 Europe winter”, the cough and cold category had been 5 down “by 7% or 8%” compared to last year. North America As aresult, the total OTCmarket during the North and 0 South-East Asia last winter period had been “pretty flat” (see -10 -5 510152025 30 Japan Figure 7onpage 21). Australiasia Three years average growth (%) “Although the global picture might not -5 exactly represent this,”Tisman cautioned, “I Figure9:OTC sales growth by region in 2013 and in the three years ended 2013 (Source –IMS OTC Global Analysis) think that directionally it is going to be correct

and Ithink when we see the first-quarter data Value growth we are going to see the moving annual target (%) growth drop noticeably.” Johnson &Johnson 3.7 +1.7 Novartis 3.7 +6.4 Emerging markets drive growth Bayer 3.6 +3.9 Looking at where the growth in the global Sanofi 3.5 +5.5 OTCmarket wascoming from, Tisman said that Pfizer 2.5 +2.0 emerging markets were still driving the gains. PGT Healthcare 2.4 +7.7 “Where we are seeing the growth is very GlaxoSmithKline 2.3 -1.2 much in the emerging markets, theynow ac- Boehringer Ingelheim 2.2 +3.8 count for over50% of the total OTCmarket- Reckitt Benckiser 1.9 +12.3 place and around 80% of total OTCgrowth,” Takeda 1.5 +8.9 Tisman pointed out. 01234 Asia-Pacific –excluding Japan –alone ac- Value share(%)

counted for athird of the growth in the OTC Figure10: Value shareand value growth of the top 10 global OTC firms in 2013 (Source –IMS OTC Global Analysis) market, he noted, while Central and Eastern Europe, the Middle East and Africa (CEEMEA) in the big markets of Western Europe and North been beneficial to Reckitt Benckiser (RB), Tis- combined with Latin America generated almost America while also taking advantage of the man added, which had had a“fantastic 2012/ half (see Figure 8). growth opportunitieselsewhere”. 2013”, especiallywith the MucinexFastMax Industry wasnow facing the “important “When we look at the one- and three-year cough and cold range in the US. challenge”, Tisman said, “of maintaining scale figures, North America and Western Europe “The other companies closest to the global have both increasedtheir growth alittle bit growth rate –Novartis and PGT Healthcare – compared to the historical picture, due to the are the ones also focused strongly on the cough Asia-Pacific* Western Europe North America cough and cold season we’ve seen in calendar and cold business,”hesaid. CEEMEA** Latin America Japan 2013,”(see Figure 9) Tisman noted. 8 100 “But Latin America, South-East Asia, and New world order in OTC 23 Central and Eastern Europe (CEE) continue to While Johnson &Johnson topped the global 11 80 growmore strongly,” Tisman said, adding that rankingsbyaslight margin, there wasa“new 17 24 the China figure was“overstated.” world order coming” in the shape of the Glaxo- 60 18 The sub-regions of Australasia had fallen SmithKline/Novartis consumerhealthcare joint 9 into decline in the past year,Tisman noted, venture (OTC bulletin,25April 2014, page 1) 40 13 22 while Japan wasstill struggling to improve. and abigger Bayer once it completed its ac- Looking at the keyfirms around the world quisition of Merck &Co’sOTC business (OTC Change (%) 20 33 23 in 2013, Tisman pointed out that during the past bulletin,9May 2014, page 1). 0 fewyears the main leading global players didn’t Who would then be number one wasanyone’s -3 seem to quite keep up with the global OTC guess, Tisman noted, as you could “cut the data -20 Share of sales Share of growth growth rate of 8.1% (see Figure 10). anywhich wayyou wanted” and it was“too close This waspartly down to the fact theywere to call”. But IMS’ data agreed somewhat with *Asia-Pacific, excluding Japan ** Central and Eastern Europe, the Middle East and Africa “not as strong in the developed markets”, Tisman the public announcements of the companies in- noted, “and partly due to the fact that the 2013 volved, he added, that GlaxoSmithKline/Novar- Figure8:Contribution to sales and growth in the global OTC market in 2013 broken down by region growth washeavily drivenbycough and cold”. tiswould be number one and Bayer number two. (Source –IMS OTC Global Analysis) The cough and cold boom, however, had OTC

22 OTC bulletin 27 June 2014 OTC27-06-14p20-23_Layout 1 26/06/2014 15:57 Page 5

PEOPLE OTC

Retailers Industr yAssociations O’Loughlin next P&G executive to replace PGEU president Mackey as CHPA chairman he Pharmaceutical Group of the Euro- TpeanUnion (PGEU) has elected Ireland’s atrick Lockwood-Taylor – Procter & Patrick Darragh O’Loughlin as its next president. PGamble’svice-president of North America Lockwood-Taylor He will take overfrom Slovakia’s Stefan Krch- Personal Health Care and Global Digestive nˇ ák in January 2015. Wellness Design –has been elected chair of the Currently secretary general of the Irish Phar- board of directors at the US Consumer Health- macyUnion (IPU), O’Loughlin has been treas- care Products Association (CHPA). urer and IPU representative for European affairs Lockwood-Taylor will replace James Mac- at the PGEU since 2013. key,senior vice-president and US region head Commenting on his newrole, O’Loughlin at Merck Consumer Care, in March next year. said he would work to ensure that pharmacists’ Mackey became chairman in March 2013 “expertise, skill and contribution to healthcare” (OTC bulletin, 29 March 2013, page 23). were recognised at anational and European level. In his 23 years at Procter &Gamble, Lock- about the “role that OTCmedicines and supple- O’Loughlin insisted that he would look to wood-Taylor has held various leadership roles ments play in our nation’shealthcare system” “maximise opportunities” to enhance pharma- at the company based across Africa, Asia, meant he was“ideally suited to serve aschair cists’ role in healthcare to benefit the profession, Europe and North America. Prior to taking up at this time of opportunity and growth”. healthcare systems and the public. his current role in 2011, Lockwood-Taylor Commenting on his new role, Lockwood- Once in post, O’Loughlin would be the third served as vice-president of North America Taylor noted that at atime of “unprecedented Irish president since the PGEU’s formation in Feminine Care. change” in healthcare, there were “more oppor- 1959, said the pharmacyorganisation, noting The CHPA’s chief executive officer Scott tunities than ever” to unlock the US consumer that Ireland had become afull member of the Melville said that Lockwood-Taylor’spassion healthcare industry’s “growth potential”. PGEU in 1964. OTC The PGEU is an association representing more than 400,000 community pharmacists Regulatory Agencies across Europe. OTC Woods re-elected as chair of EMA IN BRIEF he European Medicines Agency (EMA) EMA chair since 2011 (OTC bulletin,30June Thasre-elected Sir Kent Woods as its chair 2011, page 22). ■ AFIPA –the French OTCindustry asso- for a second three-year term. Noting that Woods had been a member of ciation –has re-elected Pascal Brossard as Woods – former chief executive officer of the EMA management board since 2004, the president for a further two years. Brossard the UK’sMedicines and Healthcare products agency pointed out that he would step down was first elected president in 2011, when he Regulatory Agency(MHRA) –has served as as chair in 2017, as the position could only replaced Vincent Cotard (OTC bulletin,29July be held for a maximum of two terms. 2011, page 26). Currently managing director Sir Kent Woods Woods served as a physician in the UK’s of Zambon France, Brossard previously held National Health Service (NHS) for 30 years management positions at Warner Lambert before taking up the role of MHRA chief exec- Consumer Healthcare, Theraplix, Celltech and utive in 2004. Nycomed. Afipa has also re-elected as vice- Commenting on his re-election, Woods said presidents Laboratoires Urgo’smanaging dir- he wasproud to lead the EMA’s management ector of healthcare Antoine Bon and Toni- board and provide “guidance and stewardship” pharm’s director general Eric Maillard. to enable the agency“to continue its role in the protection of public and animal health and ■ KEN ORR has been elected as The Phar- maintaining public trust”. macyGuild of NewZealand’snew president. OTC He replaces Karen Crisp, who had held the position since 2011. Vice-president of the asso- ciation, Orr has served on the board for the IN BRIEF past six years. The Pharmacy Guild of New ■ TEVA’s chairman of four years, Phillip mittee were “working on a succession plan”. Zealand said Orr would bring a “wealth of Frost,has announced he will cede his responsi- “With the progress we have made, and con- experience in community pharmacy” to his new bilities and step down “by the end of this year”. tinue to make, at Teva,Ihave advised the board role. David Bullen takes overfrom Orr as the Addressing shareholders in aletter published that I believe it will be appropriate for me to association’s new vice-president. on 18 June 2014, Frost, 77, said the Israeli firm’s step down,” Frost said. OTC corporate governance and nominating com- OTC

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